News Category: Regulatory news
On 26 February 2023, the EU and the UK reached political agreement in principle on the Windsor framework. The parties to the agreement are committed to take “the necessary steps to translate the joint solutions into legally binding instruments and to implement these swiftly and in good faith”.
While the agreement covers trade generally, this update only focuses on human medicines.
The Commission has published a draft regulation regarding the proposal on medicines, to reflect the agreement in principle. Its main purpose is to facilitate the supply of medicines from Great Britain (GB) to Northern Ireland (NI) and to address concerns that were raised around this linked to the implementation of the NI protocol.
Of significance in the regulation:
- Prescription medicines in NI will not be permitted to carry the safety features required under the Falsified Medicines Directive (FMD).
- New novel medicines authorised by the EU (centralised medicines) will not be permitted on the NI market, i.e., only those authorised by the UK authorities will be permitted on the NI market.
- All medicines on the NI market must have the words “UK only” on the packaging.
- The provisions do not apply to veterinary medicines.
- The new provisions are due to be implemented from 1 January 2025. This date depends on when the UK provides written guarantees to the European Commission on the protection of the integrity of the EU internal market.
Implications for Marketing Authorisation Holders (MAHs) supplying medicines to the Irish (IE) market
The Windsor agreement has implications for Marketing Authorisation Holders supplying both the IE and NI markets. In particular, companies with joint packs between GB/IE or NI/IE need to consider what it means for their products.
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Prohibition of the use of the safety feature on products placed on the NI market.
The Windsor agreement prohibits safety features appearing on the outer packaging of medicines placed on the NI market. This will, in effect, stop joint packs between NI/GB and IE.
The expiry on 31 December 2024 of the existing exemption for having to decommission product going to the UK, was already going to impact joint packs. However, it was expected that joint packs with NI would still be possible in 2025. Split batches where only the IE/NI portion was uploaded to the repository should also have been feasible.
MAHs who previously used joint GB/IE or NI/IE packs should now consider separating those packs in advance of this Windsor agreement legislation implementation.
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Special wording required for medicines placed on the NI market.
Medicines placed on the NI market must carry the wording “UK Only”. This provision also impacts the ability of MAHs to have a joint pack with IE and NI/GB particularly for OTC medicines which are not required to carry the safety features.
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Prohibition on putting EU centralised products on the NI market
The proposal prohibits placing medicines authorised by the Commission (known as centralised medicines), on the market in Northern Ireland. These medicines must be separately authorised by the UK authorities for the NI market. They must also carry the words “UK only” and not carry the safety features.
Currently many centralised products are using joint labels for the UK/NI and IE market. These marketing authorisation holders must now start planning for separate packs for the IE market. Joint packs (including where necessary multi-lingual packs) with other EU/EEA MSs remain possible.
Expiry of the existing exemptions in December 2024
As MAHs will be aware, updates to EU legislation were implemented in 2022 allowing certain exemptions for a period of 3 years. More details are available in a previous news item on the updates.
In summary they allowed:
- Continued batch release in GB,
- Continued QC testing in GB without the need for retesting on importation into the EU,
- Importation of an authorised medicine from GB by a wholesaler rather than the holder of a manufacturer’s authorisation,
- An exemption from the requirement under the Falsified Medicines Directive to decommission joint packs going to the UK market.
Some of these exemptions were notifiable to the HPRA and onwards to the Commission.
MAHs are reminded that these exemptions only apply until the end of 2024. The HPRA will write to MAHs availing of these exemptions asking them to outline their plans in respect of these medicines.
We would also invite any MAH that has concerns in relation to the impact of the Windsor agreement or the expiry of the exemptions to contact the HPRA at Brexit@hpra.ie.